FDA releases NECC inspection report

Oct. 26, 2012

Written by

Tom Wilemon and Walter F. Roche Jr.

The Tennessean

A U.S. Food and Drug Administration inspection report paints a grim picture of conditions at the New England Compounding Center, blamed for shipping contaminated medicine that is responsible for 25 deaths, including 10 in Tennessee.

The FDA found a leaking boiler surrounded by a wet floor with soiled debris 30 feet from a medicine prep room, mold and bacteria in clean rooms and greenish, yellowish residues on processing equipment at the Massachusetts compounding pharmacy.

The descriptions are included in an FDA report released today of its Oct. 2, 4, 5, 9, 15 and 26 inspections of the lab linked to a national outbreak of fungal meningitis.

Before ever putting methylprednisolone acetate vials from New England Compounding under a microscope, FDA inspectors could see “greenish black foreign matter” and “white filamentous material” floating around in the steroid solution.

The FDA said it found bacteria and mold in two of the lab’s clean rooms, the designated areas for the production of sterile drug products. Inspectors also noted failures in labeling and documentation to distinguish raw and non-sterile active pharmaceutical ingredients from sterile ones.

The FDA said it found yellow and tarnished discoloration on equipment used in the sterilization process. It also found “yellow residue” and “green residue” lining hoods of equipment used to weigh active ingredients and raw materials used to make medicines.

Foreign substances were also found on heating and cooling vent louvers behind a piece of equipment used to make bulk drug suspensions of preservative-free methylprednisolone and triamcinolone.

“A boiler installed within approximately 30 feet of the entrance to the Prep Room (ISO 8) was observed to be leaking water into puddles,” the report states. “Moreover, wet floor surfaces around the boiler appeared to be soiled with thick white debris and thick black, granular material.

“Gaps were observed between sliding doors, located in the transition between the Prep Room (ISO 8) and the warehouse, despite being fully closed. This room is used for the preparation of equipment.”